Hi everyone! Phil here. The topic of this month’s VIRB blog is going to focus on the important topic of risk assessment in research. I hope you find this informative, and you walk away thinking about how risk plays into the evaluation or research work that you may be engaging in.
What is “risk” and how do we measure it?
The currency that IRBs trade on is known as risk. Ultimately, the goal is to ensure that the risks being imposed on research participants are outweighed by the benefits of the research. The idea being that if you are going to expose people to potentially harmful stimuli, therapeutics, or processes, you better have a very good reason that will benefit not only your purposes as a researcher but also society as a whole. It is with this in mind that IRBs conduct a cost-benefit analysis as a major component of their oversight.
The best kind of risk to see is what is referred to as “minimal risk”. Essentially, minimal risk embodies the amount of risk that a person would likely experience in normal everyday life (outside of research participation). If the researcher can establish that participation carries minimal risk, then the chances that the participant will be hurt physically or mentally is rendered pretty low. It is higher risk research that is of particular concern, as it typically either involves an intervention that is either more harmful, targeting a vulnerable population, or both. Higher risk research is not uncommon, though it is probably more common in pharmaceutical and biomedical research than in behavioral (not always though) research. That said, a researcher proposing higher risk research carries a much higher burden when it comes to the cost-benefit calculation. If a research participant will assume a higher risk of harm, then the researcher needs to be able to describe not only all of the reasons why that harm is necessary, but also everything they will do to ensure the harm is mitigated to the extent possible. For example, a project may cause participants to see or experience things that may either cause trauma or re-engage old traumas, and if this is the case then the researcher needs to ensure safeguards and resources are in place to assist the participant both during and after participation.
Risk isn’t limited, however, to physical and mental harm. Things such as confidentiality practices, data storage processes, and dissemination plans contribute to the protection of participant identity both during and after their participation. Further, the presence of incentives helps IRBs understand whether any coercion may be present that may induce individuals to participate when they otherwise wouldn’t without said incentive. Additionally, consent documentation is another extremely important consideration. A hallmark of safe research practices is, after all, the presence of consent on the part of participants. Most of the time informed consent is expected, whereby participants are explicitly “informed” of everything that will happen during their participation, as well as a detailing of risks. Informed consent isn’t always practical though, especially when providing that information would affect how the individual participates in the research intervention. IRBs are extremely sensitive to the overarching risks of participation in instances where informed consent cannot be obtained, and that in combination with the other risk variables are critical elements in that overarching cost-benefit analysis.
Risk is a complex calculation relying on layered considerations and the judgment of imperfect human actuaries. We love to continue learning and teaching about how to best manage risk in research, and for that reason we would love to hear about the things you do to protect participants in your own research or evaluation work. Do you have any stories about how you and/or colleagues have worked to elevate the standards of ethical work in evaluation or ? If so, we would love to hear about it.
I look forward to connecting!
